Director, Drug Safety & Pharmacovigilance Operations

Essential Duties and Responsibilities
Leadership and Cross-Functional Partnership
- Provide hands-on functional leadership for DSPV Operations; set priorities, coordinate cross-functional and vendor resources, and drive execution.
- Serve as DSPV Operations liaison; advise on safety-operations guidance, risks, priorities, recommendations, and decisions.
- Partner with Clinical, Regulatory, Quality, Medical, Legal, Finance, Procurement, IT, and others to align safety strategy, operating models, and resources.

Safety Data Management and Reporting
- Establish and lead global safety data operating model (quality, compliance, scalability, timely delivery).
- Lead end-to-end ICSR operations (intake/triage, follow-up, data entry, coding, QA review, medical review workflow, expedited submission, case closure, reconciliation) with controls/escalation.
- Ensure quality oversight of SAEs/expedited reports (narrative accuracy, MedDRA coding, source-doc consistency, follow-up queries, remediation).
- Lead aggregate/summary safety reporting (IND Annual Reports, DSURs, PSURs/PBRERs, PADERs, integrated summaries, protocol/CSR/regulatory safety sections).
- Own safety data reconciliation across systems; resolve/escalate discrepancies.

Quality, Compliance, Inspection Readiness
- Maintain PV knowledge; lead SOP/work instruction/safety document development and lifecycle.
- Establish risk-based compliance framework.
- Own inspection readiness, internal audit support, and remediation.
- Oversee PV deviations/investigations, root-cause analyses, CAPAs, effectiveness checks; define/govern quality & compliance metrics.

Vendor, Alliance, and Technology
- Set outsourcing strategy; govern vendors (KPIs/SLAs, monitoring, escalation, action tracking, continuous improvement) and ensure timely compliant safety data exchange.
- Own budget planning and vendor financial oversight.
- Own safety database/system roadmap; direct E2B(R2/R3) reporting gateway strategy; ensure business continuity/disaster recovery.

Knowledge and Skill Requirements
- Bachelor’s degree in nursing, pharmacy, life sciences, healthcare-related field, or equivalent experience.
- 10+ years drug safety/pharmacovigilance experience; responsible for complex PV Operations and cross-functional initiatives.
- 5+ years managing third-party PV vendors/CROs and outsourced operating models.
- Experience leading cross-functional, matrixed initiatives with vendor teams (no direct people-management required).

Preferred Qualifications (examples)
- ICH/FDA/EMA/GVP expertise; experience with safety databases/MedDRA/aggregate reporting and regulatory safety submissions.
- Experience with validated PV systems (e.g., Oracle Argus Safety, ARISg), ICH E2B(R2/R3), PVAs/SDEAs, safety management/reconciliation plans, and GVP inspections.
- Signal detection/benefit-risk experience; vendor financial management and PV system implementation/UAT/process automation.

Compensation and Benefits
- Anticipated salary range: National $210,000–$250,000.
- Eligible for annual bonus and equity incentives (non-commission).
- Benefits may include medical/dental/vision, life/disability, FSAs, 401(k), paid time off/holidays.